Through its 'targeted amendment': the so-called 'export manufacturing waiver' to Supplementary Protection Certificates (SPCs), the EU executive says it wants to remove a major competitive disadvantage of EU manufacturers.

"Today we are proposing a well-calibrated adjustment to the current regime to remove a legal barrier that was preventing our companies from competing on equal terms on global markets where competition is fierce," said EC vice-president Jyrki Katainen, responsible for Jobs, Growth Investment and Competitiveness: "We want to make sure that our pharmaceutical industry reaps the benefits of such competition."

The Commission believes the proposal could generate EUR 1 billion net additional sales per year and up to 25,000 new jobs over 10 years. The proposal will particularly benefit the many small and medium-sized enterprises in the field, according to Commissioner Elzbieta Bienkowska, responsible for Internal Market, Industry, Entrepreneurship and SMEs: "In the medium term, more competition will improve patients' access to a wider choice of medicines and alleviate public budgets," she said.

Thanks to the waiver, in the future EU-based companies will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed.

With the waiver, intellectual property (IP) protection for medicine production in Europe will remain the strongest in the world and SPC-protected medicines will retain their full market exclusivity in the EU.

The proposal is accompanied by a series of safeguards which will create transparency and prevent IP-infringing products from entering Member State markets.

The proposals follows a number of studies, extensive consultation and a European Parliament resolution endorsing the need to introduce before 2019 an SPC manufacturing waiver.